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Additional Information

If the clinical trial is conducted without the use of medical devices or medicinal products there is no specific legislation in Austria. According to § 8c KaKuG (see Gesamte Rechtsvorschrift für Krankenanstalten- und Kuranstaltengesetz (Austria)/KaKuG) only an opinion from the Ethics Committee is required for a new medical method.

The Ethics Committee responsible for the physician involved must give this opinion according to the Ärztegesetz 1998 (Austria)/ Professional code of conduct for physicians 1998.
In terms of the privacy of the participants, the Bundesdatenschutzgesetz (Austria) (see also the unofficial English translation Bundesdatenschutzgesetz - Data Protection Act (Austria), English version) has to be regarded.
Furthermore the clinical trial has to be conducted in accordance with the Declaration of Helsinki.